Placeholder Banner

BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule

September 20, 2017

Dear Administrator Verma:

The Biotechnology Innovation Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Proposed Rule for calendar year (CY) 2018 (the "Proposed Rule").1 BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.

BIO members are eager to improve health care through the discovery and advancement of new therapies and thus are supportive of appropriate reimbursement in our health care system both to ensure that beneficiaries have proper access to care and to encourage investment in innovation. With these goals in mind, we have evaluated each of CMS’s proposals to ensure that they support continued access to crucial treatments and therapies in the hospital outpatient setting for Medicare beneficiaries. We briefly describe our feedback on these proposals here, and in more detail in the balance of this letter.

Specifically, although we continue to have concerns regarding the high cost threshold for packaging payment for certain drugs, certain biologicals, and therapeutic radiopharmaceuticals, BIO strongly supports CMS’s proposal to continue reimbursing separately payable drugs and biologicals at the statutory default of average sales price plus six percent (ASP+6%) in CY 2018. This methodology helps to ensure that payments are both predictable and equitable, which in turn ensures beneficiary access to vital therapies in the hospital outpatient setting. We urge CMS to finalize this proposal. We similarly encourage CMS to finalize its proposal to make transitional pass-through status payment for all drugs, biologics, and radiopharmaceuticals as close to three years as possible. Further, as detailed in the balance of this letter, BIO provides comments in support for CMS’s proposal to update the date of service policy for certain laboratory diagnostic tests and provides support for updates to the process for issuance of J-codes as a part of CMS’s request for additional flexibilities and efficiencies.

Download Full Comments Below
Final BIO Comment - OPPS CY 2018 Proposed Rule 11 September 2017
See the full comment letter here:
Discover More
We write as a coalition of advocates for the startup ecosystem to voice our strong support for the IGNITE American Innovation Act, legislation to support startups through the economic crisis by allowing companies to monetize tax assets generated…
The Biotechnology Innovation Organization (BIO) is pleased to respond to the U.S. Department of Agriculture’s (USDA) Solicitation of Input from Stakeholders on Agricultural Innovations. BIO applauds USDA for taking a proactive approach and seeking…
July 31, 2020 Re: Docket No. FDA–2020-N-0837: Raare Disease Clinical Trial Network; Request for Information. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the…